MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GREENFIELD; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number	43175
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	10/08/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device had tilted and perforated the duodenum resulting in bleeding.On (b)(6) 1994, the patient was implanted with a greenfield filter in the inferior vena cava (ivc).On (b)(6) 2016, the patient presented to the emergency room with reports of dark stool, rectal bleeding, dizziness, and weakness.The patient reported that their ivc filter had migrated, but that the location had not changed on a recent ct scan from 2 days prior.On (b)(6) 2016, the patient underwent an endoscopy procedure of the duodenum.This revealed a shallow ulcer in the second portion of the duodenum.It was observed that a metal wire type structure was penetrating the duodenal wall, with the end rubbing at the ulcer bed.Review of past ct indicated the ivc filter leg was extending into the duodenum resulting in gastrointestinal bleeding.Surgical removal of the filter was recommended.On (b)(6) 2016, the patient underwent an exploratory laparotomy in order to remove the ivc filter and repair the duodenum.The left renal vein was isolated, and the right renal vein was somewhat adhered from inflammation where the tip of the filter likely rested.In addition to the tine extending into the duodenum, 2 additional tines perforated the wall of the ivc.The filter had completely incorporated into the wall of the cava extending up into the orifice of the right renal valve.The 3 tines that had perforated the ivc were trimmed and removed.It was assessed that the filter was unlikely to migrate further, so the entire filter was not removed.The anterior cava was closed and the perforation in the duodenum was repaired.Hemostasis was achieved and no further patient complications were reported.

• Brand Name: GREENFIELD
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15279730
• Report Number: 2134265-2022-08567
• Device Sequence Number: 17763989
• Product Code: DTK
• UDI-Device Identifier: 08714729114666
• UDI-Public: 08714729114666
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1994
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 43175
• Device Catalogue Number: 43175
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male